A plethora of cold, cough, flu, and sinus relief products in various pharmaceutical combinations are marketed worldwide, with revenue projected to exceed $22.2 billion by the year 2015. This is primarily driven by a rise in the population suffering from cold, cough, and sore throat symptoms, and the introduction of effective medications.
School children are three times more susceptible to cold and cough than average adults due to underdeveloped immune systems and close contact with each other in the classroom. Colds increase during school re-opening in September and in winter.
On average, each year about one billion colds are reported and 17% of the population is infected with flu virus. Patients with heart disease, asthma, diabetes, pregnant women, the elderly, and young children are at a higher risk of exposure to flu related complications. It is estimated that about 35,000 people die each year due to flu related complications in the United States.
Nearly all cough and cold preparations contain sympathomimetic decongestants (i.e. pseudoephedrine, phenylephrine, phenypropanolamine); and pain relievers (i.e. acetaminophen, ibuprofen); and many contain sedating antihistamines (i.e. diphenhydramine, chlorpheniramine, doxylamine), dextromethorphan; and/or guaifenesin (an expectorant).
Adverse effects, particularly associated with the decongestant component, but also dextromethorphan and the sedating antihistamines have prompted the U.S. Food and Drug Administration (FDA) to recommend that Over-the-Counter (OTC) cough and cold products not be used for infants and children under 2 years of age because “serious and potentially life-threatening side effects can occur”.
The FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age, but there are reports of serious side effects including death resulting from use of cough and cold medicines in children 2 years of age and older. Also, according to the American Academy of Pediatrics, “several studies show that cold and cough products don't work in children younger than 6 years and can have potentially serious side effects”. Due to this, an FDA panel voted that cold medicine should not be used by children under 6 and although nonbinding, package labels do not recommend their use in this age group.
Decongestants, sedating antihistamines, and dextromethorphan also have significant adverse effects in adults.
Decongestants constrict blood vessels and exert effects on smooth muscle throughout the body, directly stimulate the heart and brain, dry airway secretions, and affect blood sugar. Therefore, they are generally not recommended for people with heart disease, high blood pressure, glaucoma, thyroid disease, urinary retention problems, seizure disorders, asthma, or diabetes.
They should generally not be taken with caffeine, stimulant diet pills, or monoamine oxidase inhibitors, among other drugs.
Common side effects include nervousness, restlessness, excitability, dizziness, headache, nausea, weakness, drowsiness or trouble sleeping and rapid heart beat. Patients may also experience increased blood pressure, irregular heartbeat, severe headache, tightness or discomfort in the chest, breathing problems, fear or anxiety, hallucinations, trembling or shaking, convulsions (seizures), pale skin, or painful or difficult urination.
Phenylpropanolamine (PPA), used in many products in the past, is now avoided due to possible risk of stroke.
Pseudoephedrine, once a common over-the-counter decongestant, is available only after consultation with a pharmacist in many states, since it is used to make illegal methamphetamine.
Sedating antihistamines can cause drowsiness, dizziness, and blurred vision, all of which could lead to motor vehicle and other accidents, particularly falls and fractures in the elderly. Other adverse effects include headache, loss of appetite, dry mouth, constipation, difficulty passing urine and confusion. These drugs are not recommended for people with glaucoma, enlarged prostate, high blood pressure, or seizure disorder, and should not be taken with anti-depressant, sedative, hypnotic, or tranquilizer medications.
Millions of Americans use dextromethorphan safely each year to relieve cough symptoms due to the common cold or flu. It is a non-narcotic, non-addictive cough suppressant which raises the coughing threshold in the brain and has no pain relieving properties. However, dextromethorphan may cause dizziness, lightheadedness, drowsiness, nervousness, restlessness, nausea, vomiting, and stomach pain. In addition, users of dextromethorphan may cause severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue). Furthermore, some teenagers and young adults intentionally abuse large amounts of preparations containing dextromethorphan in order to get high.
The myriad of adverse effects in various patient populations and the small potential benefit of these drugs (symptomatic relief only) versus their significant potential risk should merit exclusion of all in cold, cough, flu, and sinus preparations for children and specifically decongestants in all adults. Sedating antihistamines and dextromethorphan should also be excluded in the elderly. However, it was believed that exclusion of the sedating antihistamines and the decongestants would severely lessen or eliminate effectiveness of formulations used to treat cold, cough, flu and particularly sinus symptoms.